BEUDAMED
    FDA Recall Open, Classified

    Hintermann Series Talar Implant, Left, Size 2 REF 302112

    Recall: Z-2399-2026 · Initiated March 24, 2026

    Recall

    Recall Number
    Z-2399-2026
    Event Number
    98987
    Firm
    DT MedTech, LLC
    FEI Number
    3012104767
    Product Code
    NTG
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    March 24, 2026
    Posted
    June 10, 2026
    Address
    111 Moffitt St, Mcminnville, TN, 37110-2235

    Description

    Hintermann Series Talar Implant, Left, Size 2 REF 302112

    Reason

    Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

    Action

    On March 24, 2026, DT MedTech issued a Urgent Medical Device Recall Notification to affected consignees. DT MedTech requested that the firm take the following actions: 1. Return of all available stock of Hintermann Series Talar Implants (Part/REF number 302112, Lot number AACAA) 2. Please provide confirmation that all available stock of the part detailed below has been returned to Vilex LLC at 4516 S 700 E Suite 100A Salt Lake City, Utah 84107 USA. 3. For any questions or concerns, contact Vilex Quality at [email protected] or 800-521-5002.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.

    Quantity

    67 units